Product Liability Attorney Blog

Yet another study, this one from Canadian and Australian researchers, confirms that patients who receive the anti-bleeding drug Trasylol face a higher risk of death than those who are given cheaper anti-bleeding drugs.

Released on Dec. 2, the study reviewed findings from 49 randomized clinical trials. While Trasylol (aprotinin) was found to be more effective at controlling blood loss than lysine analogues, the higher fatality rate associated with the drug as well as its high cost outweighed the benefits.

Dr. David Henry, one of the co-authors of the study which will be published in the Jan. 20 issue of the Canadian Medical Association Journal, concluded:

"Lysine analogues are almost as effective as aprotinin in controlling blood loss, are cheaper, and appear not to increase mortality."

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Americans aren’t the only ones suffering from strokes, heart attacks and kidney failure linked to the drug Trasylol. Last Sunday, the United Kingdom’s Daily Times contained a first-person account of one man’s harrowing experience after receiving Bayer’s anti-bleeding drug.

In “The heart surgery time bomb: One man’s brush with death due to post-op drug,” Eric Clark writes that one morning, five months after major heart surgery:

“I intend to swing myself out of bed. Nothing happens, I can’t move. No worries – I obviously pulled something in the gym two days ago. I try again, and this time my grunt wakes my wife. ‘I can’t move,’ I say.

My voice sounds strange – I’m slurring my words. Now I start to panic – I am completely paralyzed. ‘Oh my God, darling, I think you’ve had a stroke.’”

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NEWS RELEASE

May 23, 2008

St. Louis – John J. Carey of the St. Louis law firm Carey & Danis has been appointed to serve as a member of the plaintiffs’ steering committee in the multidistrict Trasylol litigation pending before a Florida federal court.

On May 22, U.S. District Court Judge Donald M. Middlebrooks entered the order announcing the plaintiffs’ steering committee, which is responsible for managing and conducting the pretrial proceedings, in the case In re: Trasylol Products Liability Litigation, MDL No. 1928.

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Bayer’s anti-bleeding drug Trasyslol will now only be available for investigational use, according to a statement released by the U.S. Food and Drug Administration.

Although Bayer has agreed to remove remaining stocks of Trasylol from the U.S. market, patients who are at a higher risk for blood loss during heart bypass surgery and who have no acceptable alternative treatment may be given Trasylol. However, a doctor must first verify that the “benefits of the drug clearly outweigh the risks for their patients.”

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On the same day that the results of a long-awaited Canadian study on Trasylol were released, the drug’s maker, Bayer, announced it was pulling the anti-bleeding drug off the shelves.

Yesterday, the BART study was published in the New England Journal of Medicine. Researchers found that heart surgery patients who were given Trasylol were 53 percent more likely to die than patients who were given comparable and cheaper blood clotting drugs.

On May 14, Bayer notified the U.S. Food and Drug Administration that it will begin removing remaining Trasylol stock from the American market, most of which is in warehouses and in the possession of hospitals and physicians.

Bayer should have taken this step long ago.

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Patients who were given the anti-bleeding drug Trasylol, known generically as aprotinin, had a 53 percent higher death rate than patients who were given comparable drugs.

That’s the conclusion reached in the long-awaited Canadian study on Trasylol, known generically as aprotinin, announced today in the New England Journal of Medicine.

In an editorial that accompanied the BART study, Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University wrote:

“Thus, in all likelihood, this is the end of the aprotinin story.”

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During last Friday’s annual shareholder meeting, Bayer AG’s chief executive officer Werner Wenning announced that the drugmaker faces 78 lawsuits in the United States over the anti-bleeding drug Trasylol.

According to a Reuters news story, Wenning also stated that the company would vigorously defend the suits.

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The Associated Press reported yesterday that eight lawsuits have been filed against Bayer AG over the controversial blood-clotting drug Trasylol.

The suits were filed in Florida federal court by attorneys with the St. Louis-based law firms Carey & Danis and The Lowe Law Firm. Brought on behalf of Trasylol (aprotinin) victims and their families, the suits allege that Bayer sold an unsafe drug and failed to warn of the risks associated with its use.

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NEWS RELEASE

April 22, 2008

St. Louis – Eight lawsuits have been filed in a federal court in West Palm Beach, Fla., against Bayer AG, the maker of the anti-bleeding drug Trasylol.

The lawsuits were filed April 17 on behalf of alleged Trasylol victims and their families for injuries and deaths that occurred in California, Georgia, Indiana, Florida, Missouri, New Mexico and Wisconsin between 2000 and 2007. Specifically, the suits allege that:

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The federal lawsuits filed against Bayer AG over the anti-bleeding drug Trasylol have been consolidated and transferred to a Miami federal court.

On April 7, the transfer order was issued by the United States Judicial Panel on Multidistrict Litigation. Because of the national scope of the litigation, the common factual questions regarding the drug’s safety profile, and the similar questions raised over the adequacy of the warnings provided by Bayer, the panel concluded that consolidation was appropriate.

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The Coalition against Bayer Dangers has filed a countermotion to Bayer AG’s annual stockholder meeting agenda. The countermotion asserts that the company’s conduct violated the rules of corporate management and cites the marketing of Trasylol as one such instance of allegedly irresponsible corporate conduct.

The filing is a response to a motion made by Bayer which would ratify the actions of management during 2007. The Coalition against Bayer Dangers is urging shareholders to vote against ratification.

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Bayer, the maker of the clotting drug Trasylol, has many faces. Last September, Bayer’s representatives stood before a U.S. Food and Drug Administration advisory board and argued against changing the drug’s warning label. What they didn’t tell the board was that a Bayer-funded study found that patients given Trasylol had a 64 percent higher risk of death than patients given a comparison drug.

In an about face, Bayer agreed in November to suspend marketing of the drug after a Canadian study linked the heart surgery drug with an increased risk of death.

But in December, a straight-faced Bayer sponsored a continuing medical education program that defended Trasylol’s safety and sought to undermine earlier studies, Pharmalot reports. During the 28-minute course, four doctors not only reassured the audience that Trasylol was safe, they criticized an earlier study that warned of dangerous side effects.

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NEWS RELEASE

March 14, 2008

St. Louis – A lawsuit has been filed in a St. Louis federal court against Bayer AG, the maker of the anti-bleeding drug Trasylol, on behalf of a widow whose husband died of kidney failure after open-heart surgery.

On Dec. 16, 2005, Samuel Nakis, 81, underwent open-heart surgery at St. Luke’s Hospital in Chesterfield, Mo. During the surgery he was given Trasylol (also known as aprotinin), a clotting drug used to prevent bleeding. Shortly after the surgery, Nakis experienced kidney failure and underwent dialysis. He died a short time later.

The U.S. Food and Drug Administration approved Trasylol in 1993. On Jan. 20, 2006, the medical journal Transfusion published an article suggesting a link between Trasylol and renal toxicity. Later that same month, the New England Journal of Medicine published an article, by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, linking Trasylol to a higher risk of stroke, heart attack and kidney failure.

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Pharmalot notes that doctors at Duke University Medical Center figure prominently on both sides of the debate over Trasylol’s safety.

On one side is Dr. Peter Smith, Duke’s chief of thoracic and cardiovascular surgery. Smith is a consultant for Bayer AG, the maker of Trasylol. Last September, Smith appeared before an FDA advisory committee and testified that the anti-bleeding drug is safe and effective.

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Bayer AG, the maker of the anti-bleeding drug Trasylol, received more bad news yesterday when a federal judge in New Jersey invalidated a patent the company held the contraceptive Yasmin.

The ruling means not only that another company may be able to sell a generic version of the drug but it also calls into question whether a newer version of Yaz, which relies on the patent, will receive legal protection.

Bloomberg News reports that Yasmin is part of a group of contraceptives that brought in $1.58 billion worth of sales last year.

Ulle Woerner, an analyst at Landesbank Baden-Wuerttemberg in Stuttgart, Germany, told Bloomberg News in an interview, “Bayer's lacking a lot of positive news flow at the moment so the market is quite nervous.”

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According to a 60 Minutes investigation, it is estimated that 22,000 lives would have been saved if Trasylol, the anti-bleeding drug used in heart surgery, had been taken off the market once studies linked it to widespread deaths.

In 2006, a study conducted by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation concluded that patients who were given Trasylol had a higher risk of stroke, heart attack and kidney failure.

With the safety of a drug that was making Bayer hundreds of millions of dollars each year, and projected to hit the billion dollar mark, called into question, the manufacturer conducted its own study. It hired Alexander Walker of Harvard’s School of Public Health. He reviewed a database of 67,000 patients and came to a similar conclusion: Patients who were given Trasylol had a much higher chance of dying than patients who were given a comparable drug.

Continue reading "60 Minutes Investigates Trasylol" »

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Two new studies released last week confirm that patients given Trasylol - a clotting drug used during heart surgery to prevent bleeding - are more likely to die.

The latest studies were published in the Feb. 21 issue of the New England Journal of Medicine. According to the Associated Press, the first study looked at Duke University Medical Center patients who had bypass surgery between 1996 and 2005. Researchers found that patients who were given Trasylol were two-and-a-half times more likely to die than patients who received a different drug or no treatment for excessive bleeding.

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